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Liang X.-F.,U.S. Center for Disease Control and Prevention | Wang H.-Q.,U.S. Center for Disease Control and Prevention | Wang J.-Z.,National Institute for the Control of Pharmaceuticals and Biological Products | Fang H.-H.,National Institute for the Control of Pharmaceuticals and Biological Products | And 19 more authors.
The Lancet | Year: 2010

Background: The current influenza pandemic calls for a safe and effective vaccine. We assessed the safety and immunogenicity of eight formulations of 2009 pandemic influenza A H1N1 vaccine produced by ten Chinese manufacturers. Methods: In this multicentre, double-blind, randomised trial, 12 691 people aged 3 years or older were recruited in ten centres in China. In each centre, participants were stratified by age and randomly assigned by a random number table to receive one of several vaccine formulations or placebo. The study assessed eight formulations: split-virion formulation containing 7·5 μg, 15 μg, or 30 μg haemagglutinin per dose, with or without aluminium hydroxide adjuvant, and whole-virion formulation containing 5 μg or 10 μg haemagglutinin per dose, with adjuvant. All formulations were produced from the reassortant strain X-179A (A/California/07/2009-A/PR/8/34). We analysed the safety (adverse events), immunogenicity (geometric mean titre [GMT] of haemagglutination inhibition antibody), and seroprotection (GMT ≥1:40) of the formulations. Analysis was by per protocol. Two sites registered their trial with ClinicalTrials.gov, numbers NCT00956111 and NCT00975572. The other eight studies were registered with the State Food and Drug Administration of China. Findings: 12 691 participants received the first dose on day 0, and 12 348 participants received the second dose on day 21. The seroprotection rate 21 days after the first dose of vaccine ranged from 69·5% (95% CI 65·9-72·8) for the 7·5 μg adjuvant split-virion formulation to 92·8% (91·9-93·6) for the 30 μg non-adjuvant split-virion formulation. The seroprotection rate was 86·5% (796 of 920; 84·1-88·7) in recipients of one dose of the 7·5 μg non-adjuvant split-virion vaccine compared with 9·8% (140 of 1432; 8·3-11·4) in recipients of placebo (p<0·0001). One dose of the 7·5 μg non-adjuvant split-virion vaccine induced seroprotection in 178 of 232 children (aged 3 years to <12 years; 76·7%, 70·7-82·0), 211 of 218 adolescents (12 years to <18 years; 96·8%, 93·5-98·7), 289 of 323 adults (18-60 years; 89·5%, 85·6-92·6), and 118 of 147 adults older than 60 years (80·3%, 72·9-86·4), meeting the European Union's licensure criteria for seroprotection in all age-groups. In children, a second dose of the 7·5 μg formulation increased the seroprotection rate to 97·7% (215 of 220, 94·8-99·3). Adverse reactions were mostly mild or moderate, and self-limited. Severe adverse effects occurred in 69 (0·6%, 0·5-0·8) recipients of vaccine compared with one recipient (0·1%, 0-0·2) of placebo. The most common severe adverse reaction was fever, which occurred in 25 (0·22%; 0·14-0·33) recipients of vaccine after the first dose and four (0·04%; 0·01-0·09) recipients of vaccine after the second dose compared with no recipients of placebo after either dose. Interpretation: One dose of non-adjuvant split-virion vaccine containing 7·5 μg haemagglutinin could be promoted as the formulation of choice against 2009 pandemic influenza A H1N1 for people aged 12 years or older. In children (aged <12 years), two 7·5 μg doses might be needed. Funding: Sinovac Biotech, Hualan Biological Bacterin, China National Biotec Group, Beijing Tiantan Biological Products, Changchun Institute of Biological Products, Changchun Changsheng Life Sciences, Jiangsu Yanshen Biological Technology Stock, Zhejiang Tianyuan Bio-Pharmaceutical, Lanzhou Institute of Biological Products, Shanghai Institute of Biological Products, and Dalian Aleph Biomedical. © 2010 Elsevier Ltd. All rights reserved.

Sun W.,College of Logistics | Deng C.,College of Logistics | Hao H.,College of Logistics | Kang Y.,Beijing Tiantan Biological Products | Si Y.,College of Logistics
Materials Letters | Year: 2013

A novel nano carbon network composed of multi-walled carbon nanotubes (MWCNTs) and acetylene black (AB) were used as coating materials for LiFePO 4. LiFePO4 particles were connected by multi-walled carbon nanotubes to form a three-dimensional network coating and acetylene black repaired the incomplete carbon coating areas. This nano network structure can improve cyclic performance of the cathode composite effectively. The initial discharge capacity of LiFePO4/5 wt% MWCNTs+5 wt% AB was 161.3 mAh/g at 0.2 C. Besides, the cycling performance was also improved by such kind of coating, SEM images showing the change of electrodes after cycles were also displayed. © 2012 Elsevier B.V.

Zhang Y.,Beijing Tiantan Biological Products | Chen X.,Beijing Tiantan Biological Products
Chinese Journal of Biologicals | Year: 2014

The monitoring of residual DNA (rDNA) is necessary to most of biologics in market and in development. The illustration of potential hazard of rDNA which is considered as a host-associated impurity and demonstration of removal of rDNA to an acceptable and/or consistent levels in bioprocess by using applicable methods are very important to the production and development of biologies. This paper reviews the progress in study on of potential hazard and test method of residual DNA in biologies.

Guo S.H.,Beijing Tiantan Biological Products
Zhongguo ji hua mian yi = Chinese journal of vaccines and immunization | Year: 2010

OBJECTIVE: To evaluate the safety and Immunogenicity of the Poliomyelitis vaccine (Human Diploid Cell) in > or =2 month-old children. METHODS: A random, blind and control trial, 1200 healthy children of 2-5 months old in Jiangsu province were administered OPV (HDC) vaccine and control vaccines. The antibody was tested by neutralization test. RESULTS: After 3 doses of the OPV (HDC) vaccine, the systemic reactions were mild. After 1 month of vaccination with 3 doses of the OPV (HDC) vaccine, the immune success rates of I, II, III type were 98.28%, 99.45%, and 95.71% respectively, the GMTs of I, II, III type in susceptible children were 1:1243.72, 1:234.38 and 1:273.10 respectively. CONCLUSIONS: The OPV (HDC) vaccine was safe and immunogenicity for the children > or =2 months old.

Ye X.,Beijing Tiantan Biological Products
Chinese Journal of Biologicals | Year: 2012

Objective: To analyze the characteristics of suspected adverse events following immunization (AEFI) in Harbin City, China in 2011 and evaluate the AEFI surveillance system. Methods: A descriptive analysis was performed on the data on AEFI reported in Information Management System of AEFI in Harbin in 2011. Results: A total of 188 cases of AEFI were reported in Harbin in 2011, most (86.7%) of which were general reactions. However, 72.9% of the cases were reported from July to December. Most of the cases were observed in the infants at ages of not more than 1 year and more than 1 year but not more than 2 years, which accounted for 42.0% and 36.2% of the total number respectively. A portion of 49.5% of the cases were observed after immunization with DTaP, which might be due to the increased doses. Of the general reactions, 85.1% were fever/redness and swelling/induration. Conclusion: The timely report rate and timely investigation rate of AEFI as well as timely submission rate of investigation table were high in Harbin City. However, the training and supervision on the personnel in grass-root units should be strengthened. Meanwhile, direct network should be established in the units at town level so as to further improve the sensitivity and punctuality of AEFI surveillance system.

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